Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT03365479|
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
• To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension
- To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).
- To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Pulmonary Arterial Hypertension||Drug: Iloprost||Not Applicable|
This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost (2.5μg) during right heart catheterization (RHC) using the Breelib nebulizer. Patients with confirmed diagnosis of pulmonary arterial hypertension (PAH = WHO group 1), NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC. As a proof-of concept design, the study will include consecutive PAH patients only challenged with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer during right heart catheterization (day 2).
The acute hemodynamic response will be followed over 30 minutes. Change of pulmonary hemodynamics, systemic blood pressure, right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5, 10, 15, 30 minutes after the end of inhalation.
Recently, the Breelib nebulizer has been evaluated within a multicenter, randomized, unblinded, study. This safety and feasibility study compared inhalation time, pharmacokinetics, and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer. The primary safety endpoints (AEs) were reported with a low frequency and were consistent with the known safety profile of iloprost. Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher, with Breelib versus I-Neb. Previously, it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI. Moreover, previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation.
Therefore, the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 2.5 μg iloprost delivered via the Breelib device. The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance (PVR). Moreover, as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure, cardiac index/cardiac output, systemic blood pressure, right ventricular echocardiographic parameters and oxygen saturation after inhalation of 2.5μg iloprost and analyze adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: Study cohort
The study comprises a 1-day Screening period, followed by a right heart catheterization with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
- Change of PVR (∆PVR) [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of mPAP [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of PAWP [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of CI [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of systemic blood pressure [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of oxygen saturation [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
- Change of right heart echocardiography [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
- Adverse events (AEs) [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365479
|Contact: Manuel Richter, MDfirstname.lastname@example.org|
|University Clinic Giessen and Marburg||Recruiting|
|Giessen, Hesse, Germany, 35392|
|Contact: Heuser Sina +4964198557043 email@example.com|
|Contact: Henning Gall, PhD +4964198556766 firstname.lastname@example.org|
|Principal Investigator: Ardeschir Ghofrani, Prof.|
|Sub-Investigator: Manuel Richter, MD|
|Sub-Investigator: Natascha Sommer, PhD|
|Sub-Investigator: Henning Gall, PhD|
|Sub-Investigator: Khodr Tello, MD|
|Sub-Investigator: Jan Grimminger, MD|
|Kerckhoff-Klinik||Not yet recruiting|
|Bad Nauheim, Germany|
|Contact: Andreas Rieth, MD +49 60 32 99 60 email@example.com|